APPLICATION
ANDA075243
TYPE
ANDA
ORIGINAL APPROVAL
2000-06-20
LATEST ACTION
2023-01-17
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MIDAZOLAM HYDROCHLORIDEPrescription
MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML · INJECTABLE · INJECTION
MIDAZOLAM HYDROCHLORIDEPrescription
MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-01-17Labeling · Supplement 38 · standardAP
2021-11-10Labeling · Supplement 36 · standardAP
2017-04-27Labeling · Supplement 26 · standardAP
2009-05-08Labeling · Supplement 18AP
2009-03-03Labeling · Supplement 12AP
2003-12-04Labeling · Supplement 4AP
2000-11-30Manufacturing (CMC) · Supplement 1AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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